Complementing the authors first book, analytical method validation and instrument. Amplelogic electronic log book or elogbook software is a webbased solution. The calibration logbook should also be used when a technician takes the instrument out of service for repairs or training purposes. Calibration logbook record calibration results alcopro. Electronic equipment logbook opstrakker mobile app.
Calibration is basically comparing the measurements made by a device against a reference instrument or standard to check its precision, accuracy and limits. Periodic general maintenance of the hplc is one type of service procedure which should be. Prior to removing an instrument from service, a final calibration shall be performed, if possible i. End users can design log forms as per their approved sops. Gmp guitars strives to produce the highest quality custom instruments on the market today. All companies are required to keep a logbook for the chronological documentation of equipmentrelated events such as validation and. Who defines good manufacturing practices gmp as that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their. Good manufacturing practice regulations require an active training program and the documented evaluation of the training of analysts.
Summarizing these regulations, the logbook entries must be. This record, in turn, holds significance for various organizations where different types of apparatus, appliances or articles are used. This standard operating procedure is applicable for maintaining of equipment log book associated with product s manufactured at formulation plant. Good laboratory practice with a uvvisible spectroscopy system application note uvvisible spectroscopy anthony j.
It is a diverse community of more than 9,000 professionals united by one important. Installation qualification and operation qualification iqoq. How to implement good documentation practices pharmout pty ltd, abn. Sop on maintaining of equipment log book pharmaceutical. An electronic equipment logbook app ipad android pc that replaces paper based equipment use logs eul in fda regulated gmp manufacturing facilities. When a new dry gas tank is received, the technician should record the. Titrator annexure and note down the instrument id in protocols of analysis. Good practice gxp regulations require an instrument maintenance and use log. Electronic log book elogs for the pharmaceutical industry. Maintenance and servicerelated items are often the secondlargest budget element in a laboratory after salaries and benefits. The instrument or equipment records are compiled and required information maintained in a readily accessible manner. Practical approaches to ensure that analytical methods and instruments meet gmp standards and requirements.
Manual of food safety management system, fss act 2006 ranjan saha. Importance of maintaining laboratory log books lab. Preventive maintenance strategies for the pharmaceutical. Ensure that instrument is clean and free from dust. Logbooks required are determined by gmp requirements for the traceability of data, events, and communications. The batch number should be immediately recorded in a logbook or by. A laboratory log book is a tamper proof record of laboratory activities related to use of testing equipments, environmental conditions in laboratory and. Procedure for instrument log books nc state university. Guide to fda approval process and importance of equipment. Practical approaches to method validation and essential. To lay down a procedure for maintaining of equipment log book. Within maintenance, preventive maintenance pm is a substantial portion of the.
Documentation and records, good manufacturing practices, quality assurance. This standard operating procedure is applicable for maintaining of equipment log book associated with product s. If the fda inspections identify deviations from the regulations, they will issue inspectional observations using. Bpn product description inprocess finished goods or final packed product code no. The instrument specification record shall be attached to the instrument change record form. Good manufacturing practices gmp are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of. These include factories, science research labs, and workshops among many others. If you need another practice chart or log, click below to print another copy. Volume 4 of the rules governing medicinal products in the european union contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products. Have spectroscopy laboratories and software suppliers. Amplelogic electronic log book is a webbased software or platform that records general production requirements and tracks down area and. Creation and use of gmp equipment logbooks free gmp sop. Gmp instruments, saintsauvant, poitoucharentes, france. Register logbook recording, in sequence, all production.
Instrument system log book ensures a complete record of activities is maintained. Owen the objective of good laboratory practice glp is to obtain accurate. The basic rules in any good manufacturing practice gmp regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records. For problems with instruments, please list the symptoms. Table i lists the glp and gmp requirements for an instrument maintenance and use log. The application is compliant with fda requirements for cfr title 21 including 21 cfr part 11 that outlines electronic records and signatures. Good laboratory practice with a uvvisible spectroscopy. If this is the case, print a new log sheet and replace the completed one with the new one. This record, in turn, holds significance for various organizations where different types of apparatus, appliances or articles are. Maintaining an equipment logbook is a mandatory requirements as per fda. Good laboratory practices, good clinical practices, and good manufacturing practices. Users can capture logs through mobile devices by simply scanning the qr code available at the equipment, instruments andor clean rooms, with or without.
Complete instrument history the instrument system log book is an integral part of the iqoq program as it ensures a. All the concerned personnel shall be responsible to follow the procedure for maintaining of equipment log book. An instrument log book should be employed to document these procedures over time. The facilities system elements examine the general. Gamp, good manufacturing practice gmp, standard operating procedures. Electronic log book pharmaceutical logbook software amplelogic. All companies are required to keep a logbook for the chronological documentation of equipmentrelated events such as validation and qualification work, calibration, equipment cleaning, preventive. Equipment records page 1 of 6 sections in this document.
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